510(k) · Cleared
Recalled · Class II · 2021Natus Neuroworks, Model 104196
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical, Inc. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Feb 22, 2010 after a 416-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2010
- Review
- 416 days
- Class
- Class II
- Product code
- OMB
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK090019 Natus Neuroworks, Model 104196Natus Medical, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK180421 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018
- Descendant · 2 generations on · 1 of its ownK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- Descendant · 3 generations on · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
- Descendant · cites it directly · 0 of its ownK123665 Lifelines IeegKvikna Ehf · 2013
- Descendant · cites it directly · 0 of its ownK120260 ICTAExcel-Tech Ltd. (Xltek) · 2012
Most influential descendants
Showing 5 of 5 · See all- K180421Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · cites it directly2descendants
- K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020 · 2 generations on1descendant
- K251881HippoMind (v1.0)Hippoclinic · 2025 · 3 generations on0descendants
- K123665Lifelines IeegKvikna Ehf · 2013 · cites it directly0descendants
- K120260ICTAExcel-Tech Ltd. (Xltek) · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090019 | Natus Neuroworks, Model 104196 | Natus Medical, Inc. | 2010 | — |
| +1 | K180421 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | — |
| +2 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| +3 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
| +1 | K123665 | Lifelines Ieeg | Kvikna Ehf | 2013 | — |
| +1 | K120260 | ICTA | Excel-Tech Ltd. (Xltek) | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2021 | Class II | Z-0661-2022 | Process change control | Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K180421 (Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Neuroworks is EEG software that displays physiological signals. The intended User of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. * The Neuroworks EEG software allows acquisition, display, archive, review and analysis of physiological signals. * The Seizure Detection component…
Read the full statement (261 words)
The Neuroworks is EEG software that displays physiological signals. The intended User of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
* The Neuroworks EEG software allows acquisition, display, archive, review and analysis of physiological signals.
* The Seizure Detection component of Neuroworks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
* The Spike Detection component of Neuroworks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
a The aEEG functionality included in Neuroworks is intended to monitor the state of the brain. The automated event marking function of Neuroworks is not applicable to aEEG.
* Neuroworks also includes the display of aquantitative EEG plot, Compressed Spectrum Array (GSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Neuroworks is not applicable to GSA.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090019: Natus Neuroworks, Model 104196.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026